Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

5726–5750 of 27393

HighFDA (Devices)·Z-1419-2024·2024-04-10
Exactech Equinoxe Shoulder Implants Recalled Due to Nonconforming Oxygen Barrier Packaging
Exactech is recalling 7,213 units of Equinoxe REVERSE SHOULDER prosthetic liners due to nonconforming packaging. The vacuum bags lack the required oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH) specified for these devices.
Product
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1444-2024·2024-04-10
Medline Centurion surgical scissors recalled due to weak seals
Medline Industries is recalling Centurion surgical scissors due to potentially weak seals that may compromise sterility. Users cannot reliably detect the defect, creating risk if compromised instruments are used in surgery.
Product
Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" (I142), Product Code 65940; c) STERILE S/B SCISSOR 5-1/2" (I140), Product Code 65945; d) STERILE CURV IRIS SCISSOR (IC164), Product Code 66
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1427-2024·2024-04-10
Centurion Sterile Trach Brush Recalled Due to Weak Seal
Medline Industries is recalling 1700 Centurion Sterile Trach Brush devices due to a potential weak seal that may breach product sterility if the seal fails. The defect may not be obvious to users.
Product
Centurion STERILE TRACH BRUSH, Product Code 6225ST
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1463-2024·2024-04-10
Coloplast Ureteral Dilators Recalled Due to Sterile Packaging Issue
Coloplast Manufacturing is recalling 710 ureteral dilators due to a possible breach in sterile packaging detected during facility testing. The devices are distributed across multiple US states.
Product
Ureteral dilator, REF RBD014
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1466-2024·2024-04-10
Covidien Auto Suture Blunt Tip Trocar Recalled for Seal Disengagement Risk
Covidien Auto Suture Blunt Tip Trocar devices are recalled due to potential seal disengagement when using mesh products incorrectly with the device. This malfunction risk affects surgical procedures.
Product
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1411-2024·2024-04-10
Exactech Equinoxe Shoulder Implants Recalled for Nonconforming Packaging
Exactech is recalling 245 units of shoulder implants due to nonconforming packaging that lacks a required oxygen barrier layer. The devices were distributed nationwide and internationally.
Product
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-32, b) 41, 44, 47, 50 head, Medium, Item Number314-06-33, c) 44, 47, 50, 53 head, Large, Item Number 314-06-34, d) 44,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1431-2024·2024-04-10
Centurion Dental Kits Recalled for Weak Seal Risk
Medline has recalled Centurion dental kits due to weak seals that may compromise sterility. No illnesses or injuries have been reported.
Product
Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6; c) DENTAL INSTRUMENT KIT, Product Code DH760
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1448-2024·2024-04-10
Medline Centurion Manual Surgical Kits Recalled for Weak Seal Risk
Medline Industries is recalling 1700 units of Centurion Manual surgical kits due to potential weak seals that could compromise sterility. The weak seal may not be detectable by users.
Product
Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOSABLE BAG, Product Code MG912ST
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1403-2024·2024-04-10
Exactech Equinoxe shoulder components recalled for nonconforming packaging
Exactech is recalling 2,008 Equinoxe shoulder implant components due to packaging that lacks a required oxygen barrier layer. The defect does not meet product specifications.
Product
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1451-2024·2024-04-10
Centurion umbilical cord clamp cutter recalled for potential sterility breach
Medline's Centurion umbilical cord clamp cutters may have weak seals that could compromise sterility. The defect may not be detectable during normal inspection.
Product
Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1432-2024·2024-04-10
Laryngeal Mirror Weak Seal May Breach Sterility
Medline is recalling Centurion STERILE #5 Laryngeal Mirrors due to weak packaging seals that may not be detectable by users. The defect could result in a breach of the product's sterility if the seal fails.
Product
Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1446-2024·2024-04-10
Sterile Rubber Band Recall for Weak Seal Risk
Medline Industries, LP is recalling Centurion STERILE #16 rubber bands because the package seal may be weak, potentially compromising product sterility. The defect may not be visible to users before opening.
Product
Centurion STERILE #16 RUBBER BAND, Product Code EB16
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1392-2024·2024-04-10
X-Guide Handpiece Adaptor Sleeve defect affects fit on dental handpiece
The X-Guide Handpiece Adaptor Sleeve 1 may have a manufacturing defect causing incorrect geometry that prevents proper fit on dental handpieces. Approximately 88 units are affected.
Product
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1436-2024·2024-04-10
Centurion Scalpel Handles Recalled Due to Weak Seal Risk
Medline Industries is recalling Centurion scalpel handle kits due to weak seals that may compromise sterility. Users cannot always detect the defect.
Product
Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1417-2024·2024-04-10
Exactech Equinoxe Reverse Shoulder Implants Recalled for Nonconforming Packaging
Exactech is recalling 826 Equinoxe Reverse Shoulder humeral liners (Item Numbers 320-36-10 and 320-36-13) due to nonconforming packaging. The vacuum bags lack the required oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Product
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1462-2024·2024-04-10
Mobile X-ray System Structural Cable Defect Affects Safety Function
Agfa DX-D 100 mobile X-ray systems have a structural cable defect in the support column that may prevent the safety mechanism from blocking the arm if the cable fails, potentially resulting in patient injury.
Product
Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1407-2024·2024-04-10
Exactech Equinoxe Shoulder Glenoid Components Recalled for Defective Packaging
Exactech is recalling 985 shoulder implant components due to nonconforming packaging that lacks a required oxygen barrier layer. The vacuum bags do not meet packaging specifications.
Product
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 he
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1415-2024·2024-04-10
Exactech Shoulder Implant Components Recalled for Inadequate Oxygen Barrier Packaging
Exactech Equinoxe shoulder implant components (4,007 units) are recalled because their vacuum-sealed packaging lacks a required oxygen barrier layer, potentially allowing material degradation.
Product
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Ext
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1469-2024·2024-04-10
Covidien Auto Suture blunt tip trocar recalled for seal disengagement
Covidien recalls its Auto Suture blunt tip trocar (OMS-T10BTS) due to potential seal disengagement when mesh products are used incorrectly, affecting approximately 18,048 units worldwide.
Product
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1450-2024·2024-04-10
Centurion Manual Uterine Dilator Surgical Kits Recalled for Weak Seal
MEDLINE INDUSTRIES is recalling Centurion Manual uterine dilator surgical kits due to weak seals that may breach sterility. The weak seal could allow contamination and may not be detectable by users.
Product
Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM, STERI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1402-2024·2024-04-10
Exactech Equinoxe Glenoid Shoulder Components Recalled for Nonconforming Packaging
Exactech, Inc. is recalling 2,077 units of Equinoxe Glenoid shoulder components due to nonconforming packaging. The affected units were packaged in vacuum bags lacking the required oxygen barrier layer.
Product
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1454-2024·2024-04-10
Medline wire cut scissors may have weak seal compromising sterility
Medline Industries is recalling 800 units of 4.5-inch wire cut scissors due to a weak seal that could compromise sterility if it fails during use or storage.
Product
MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1428-2024·2024-04-10
Medline Pediatric Magill Catheter Recalled for Weak Seal Risk
Medline is recalling its Centurion FCP Magill Catheter (7.5 in. pediatric) because the product may have a weak seal that could compromise sterility. The affected units were distributed in the US, Panama, and Canada.
Product
Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1439-2024·2024-04-10
Centurion Curette kits recalled for weak seals potentially compromising sterility
Medline Industries is recalling Centurion Curette kits because some may have weak seals that could compromise product sterility. The weak seal may not be detectable during inspection.
Product
Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c) STERILE FOX DERMAL CURETTE, 5MM(32923), Product Code 67430; d) STERILE EXCAVATOR CURETTE (P/S), Product Code I67970
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1478-2024·2024-04-10
Skull Anchor Key Defect Prevents CT Localizer Attachment
Navinetics Inc. has recalled the NaviNetics Skull Anchor Key and Drill Kit (Lot 331401724) because the skull anchor key may fail to allow proper attachment of the CT localizer, preventing stereotactic imaging procedures.
Product
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Category
Medical Device
Distribution
Distributed nationwide

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5726–5750 of 27393